Licensing of manufacturing and maintenance (except cases, when maintenance is carried out for legal entity or individual entrepreneur’s own needs) of medical equipment is performed by the central office of the Federal Service on surveillance in healthcare in accordance with the main principles of licensing of certain types of activities on the territory of the Russian Federation.
Main objectives:
Provision of the state service of licensing of manufacturing and maintenance of medical equipment.
The service is provided in accordance with the Federal Law dated July 27, 2010 № 210-FZ “On Organization of Provision of State and Municipal Services”.
Control over licensing of manufacture and maintenance of medical equipment.
Control over execution of requirements for licensing is performed in accordance with a plan of inspections, agreed with the Prosecutor General’s office of the Russian Federation as per the Federal Law dated December 26, 2008 № 294-FZ “On Protection of Rights of Legal Entities and Individual Entrepreneurs when Exercising State Control (Supervision) and Municipal Control”.